The U.S. Department of Justice (DOJ) announced on July 30, 2013 that it had reached a settlement with Wyeth Pharmaceuticals to resolve criminal and civil liability related to the unlawful marketing of its prescription drug Rapamune for uses not approved by the U.S. Food and Drug Administration (FDA) that caused false claims to be submitted to federal health care programs. The $491 million settlement includes a $257.4 million civil settlement, criminal fine of $157.58 million and $76 million in forfeited assets. Additionally, Wyeth will plead guilty to one count of misdemeanor misbranding for Rapamune under the Federal Food, Drug, and Cosmetic Act (FDCA). The settlement resolves two False Claims Act (FCA) whistleblower complaints, one originally filed in 2005 by a former Rapamune sales representative and a pharmacist and the second originally filed in 2007 by another former Rapamune sales representative.
The investigation of Wyeth began in October 2009 and related to alleged conduct from 1998 to 2009. According to the criminal information, Wyeth marketed Rapamune for unapproved uses, including for use in non-renal transplant patients even after a boxed warning was added to the label. The criminal information also states that Wyeth employees were trained on off-label uses of the product and compensated for all product sales, including off-label uses. The government further alleges that Wyeth used Transplant Science Liaisons (TSLs), similar to the medical science liaison (MSL) role of other pharmaceutical manufacturers, as part of its off-label marketing campaign, including close coordination with the sales team at sales meetings, sales calls and off-label presentations to health care professionals.
Wyeth, now part of Pfizer, is subject to Pfizer’s 2009 corporate integrity agreement (CIA). The CIA will not be modified due to this settlement.